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Genteric Announces Issuance of Landmark Gene Pill--TM-- Patent; New Patent Claims Oral DNA Delivery Platform Covering All Secreted Proteins.


Business Editors & Health/Medical Writers

BIOWIRE2K

ALAMEDA, Calif.--(BW HealthWire)--July 19, 2001

Genteric Inc., a private biotechnology company focused on providing a new generation of gene therapy and protein drug delivery technology, announced today it has been awarded U.S. Patent 6,258,789 for a method of oral delivery of DNA DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
 to include all secreted proteins for the treatment of such diseases as hemophilia and anemia. This patent follows the recent issuance of U.S. Patent 6,225,290, which was awarded to Genteric in May for the first ever oral delivery of non-viral DNA encoding the human insulin human insulin
n.
A protein that has the normal structure of insulin produced by the human pancreas but that is prepared by recombinant DNA techniques and by semisynthetic processes.
 gene for the treatment of diabetes.

Genteric's Gene Pill(TM) technology enables the oral administration of an engineered gene that encodes a therapeutic protein. The gene is taken-up by cells of the intestine which then produce the protein. Once the protein is produced, it is secreted into the patient's bloodstream providing the desired therapeutic effect. This revolutionary approach will likely replace many of the current array of injectable in·ject·a·ble
adj.
Capable of being injected. Used of a drug.

n.
A drug or medicine that can be injected.
 protein drugs. The market for injectable proteins exceeds $20 billion and includes blockbuster medications such as human insulin, EPO EPO

see erythropoietin.

EPO Erythropoietin, see there
, human growth hormone human growth hormone (HGH): see growth hormone. , Factor VIII factor VIII
n.
A factor in the clotting of blood, a deficiency of which is associated with hemophilia A. Also called antihemophilic factor, antihemophilic globulin, antihemophilic globulin A,
 and Factor IX. The Gene Pill applications for these drugs and many more are claimed within the new patent. The Company believes this technology platform will also spawn the development of many new protein drugs, which will otherwise not come to market because of their prohibitive development costs or other complications.

"Our Gene Pill program represents the final frontier to realizing the promise of uncomplicated gene therapy together with the effort of sequencing the human genome The human genome is the genome of Homo sapiens, which is composed of 24 distinct pairs of chromosomes (22 autosomal + X + Y) with a total of approximately 3 billion DNA base pairs containing an estimated 20,000–25,000 genes. ," said Martin D. Cleary, president and chief executive officer of Genteric. "Although much work needs to be done, our patent position will now ensure Genteric owns the necessary intellectual property to lead the commercialization effort. We are eager to partner this program with forward thinking pharmaceutical and biotech companies and advance this technology to the clinic."

"Although this technology is in the early stages of development, the data shows promise of enhancing the quality of life for patients suffering from these sometimes debilitating de·bil·i·tat·ing
adj.
Causing a loss of strength or energy.


Debilitating
Weakening, or reducing the strength of.

Mentioned in: Stress Reduction
 illnesses," remarked Roland Scollay, Ph.D., Genteric's vice president of research and chief scientific officer. "This patent solidifies Genteric's unique approach to gene therapy providing the opportunity to replace current protein therapy modalities by making it more efficient, cost effective and safer to administer to patients."

Genteric's Gene Pill Approach

Researchers from Genteric have invented a new method of gene delivery that employs the patient's own gastrointestinal tract gastrointestinal tract
n.
The part of the digestive system consisting of the stomach, small intestine, and large intestine.


Gastrointestinal tract 
 to produce and secrete secrete /se·crete/ (se-kret´) to elaborate and release a secretion.

se·crete
v.
To generate and separate a substance from cells or bodily fluids.
 therapeutic proteins into the bloodstream. In the therapy's mature stage, the patient could swallow a pill containing engineered DNA that encodes the needed protein. The DNA would then be "taken up" by the cells lining the luminal space of gastrointestinal tract (the side of the intestine that normally absorbs food material), which then produce and secrete proteins into the bloodstream to achieve the desired therapeutic results. A key feature of these intestinal cells is that, like skin cells, they are constantly replaced. Thus, the gene is expelled with the dying cells on a regular basis -- about every other day. This natural feature enhances safety and efficient dose control.

This new oral gene therapy method presents the following advantages:
-- Oral administration is simple, painless and convenient.

-- Oral administration allows different dose levels to be given according to
patient needs.

-- The body replaces cells at this site quickly, which gives greater control of
gene delivery and helps to avoid long-term side effects.


Genteric's next steps are to continue current experiments and follow into Phase I/II clinical trials. During these stages, researchers will address challenges in oral delivery, such as methods to adjust the amount of protein expressed and durability of coating materials used to protect the DNA as it is delivered to cells in the intestinal tract.

About Genteric, Inc.

Established in 1997, Genteric is a privately held biotechnology company, which owns exclusive rights to several proprietary technology platforms invented at both the San Francisco and Davis campuses of the University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). . The company has pioneered new methods of gene-based drug delivery that employ the secretory secretory /se·cre·to·ry/ (se-kre´tah-re) (se´kre-tor?e) pertaining to secretion or affecting the secretions.

se·cre·to·ry
adj.
Relating to or performing secretion.
 organs of the patient's gastrointestinal system gastrointestinal system: see digestive system.  to produce and release therapeutic proteins into the bloodstream.

The company encourages inquiries regarding licensing and partnering opportunities for its technologies.

For additional information, please visit Genteric's web site at www.genteric.com.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jul 19, 2001
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